Taiwan FDA registration 2289519aae9084e2f67d9159fdd6141a

"Billy" Hand Ophthalmic Surgical Device (Inverted)

TW: "碧利" 手動式眼科手術器械(未滅菌)

Taiwan·Risk Class 1·Belle Healthcare Technology Co., Ltd.·Registered Nov 19, 2024 – Nov 19, 2029Active

Registration details

Analysis ID: 2289519aae9084e2f67d9159fdd6141a
Customs Code: DHA09600503405

Company information

Manufacturer: Belle Healthcare Technology Co., Ltd.
Manufacturer Country: China
Authorized Representative: CRYSTALVISION CO., LTD.

Product details

Intended Use: It is limited to the first level of identification of the "Manual Ophthalmic Surgical Instruments (M.4350)" of the Administrative Measures for the Classification and Grading of Medical Devices.
Product Type (Level 1): M Ophthalmology
Product Type (Level 2): M.4350 手動式眼科手術器械
Import Information: Chinese goods;; Input;; QMS/QSD

Dates and status

Registration Date: Nov 19, 2024
Expiry Date: Nov 19, 2029

About this record

Access comprehensive regulatory information for "Billy" Hand Ophthalmic Surgical Device (Inverted) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2289519aae9084e2f67d9159fdd6141a and manufactured by Belle Healthcare Technology Co., Ltd.. The authorized representative in Taiwan is CRYSTALVISION CO., LTD..

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